Application 020834

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROGAINE EXTRA STRENGTH (FOR MEN)	MINOXIDIL	SOLUTION;TOPICAL	5%	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-4805	Qilib Hair Regrowth Treatment for Men	MINOXIDIL	Galderma Laboratories, L.P.	NDA	Current
0299-4820	Qilib Hair Regrowth Treatment for Women	MINOXIDIL	Galderma Laboratories, L.P.	NDA	Current
63981-111	Mens Kirkland	Minoxidil	Costco Wholesale Corporation	NDA	Current
69968-0089	Mens Rogaine Extra Strength Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0089	Mens Rogaine Extra Strength Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0089	Mens Rogaine Extra Strength Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current